Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 7, 2005

Last Updated Date

February 9, 2009

Start Date ^†

June 2005

Current Primary Outcome Measures ^†

Sleep latency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Total sleep time [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Sleep latency
Total sleep time

Change History

Complete list of historical versions of study NCT00120250 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Symptoms of Posttraumatic Stress Disorder [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Sleep quality [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Symptoms of Posttraumatic Stress Disorder
Sleep quality
Quality of life

Descriptive Information

Brief Title ^†

Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder

Official Title ^†

Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder

Brief Summary

The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.

Detailed Description

Post-traumatic stress disorder (PTSD) is characterized by three symptom groupings: re-experiencing symptoms including flashbacks, nightmares, and intrusive memories; physiological hyperarousal; and avoidance symptoms. Of the three major categories of symptoms in PTSD listed by the Diagnostic and Statistical Manual of Mental Disorders, sleep-related problems are listed in two of them: difficulty falling asleep is considered an aspect of hyperarousal symptoms, and nightmares are a type of re-experiencing symptom. Both are found commonly in PTSD. Little is known about the relationship of neuroendocrine dysregulation in PTSD and sleep disturbance. It is possible that successful treatment of sleep disturbance in PTSD may alter an abnormal stress hormone pattern. The novel cyclopyrrolone hypnotic eszopiclone thus presents an intriguing opportunity to examine the treatment of sleep disturbances and nightmares in PTSD. This study will determine the safety, efficacy and impact on neuroendocrine parameters of eszopiclone compared to placebo for sleep disturbance and overall PTSD symptoms in individuals with PTSD and reported sleep disturbance.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^†

Post-Traumatic Stress Disorders

Intervention ^†

Drug: Eszopiclone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Male or female outpatients 18-64 years of age with a primary diagnosis of PTSD as defined by DSM-IV criteria with associated sleep disturbance

Exclusion Criteria:

Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception.
Concurrent use of other psychotropic medications, other than antidepressants at stable dose for at least 4 weeks prior to randomization
Serious medical illness or instability
Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood
Concurrent psychotherapy initiated within one month of randomization or ongoing psychotherapy of any duration directed specifically toward treatment of PTSD and/or sleep disturbance
Diagnosis of schizophrenia, mental retardation, OCD, organic medical disorders or bipolar disorder, eating disorders in the past 6 months, alcohol or substance abuse in the past 3 months, or dependence within the past 6 months.
Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00120250

Responsible Party

Mark Pollack, M.D., Center for Anxiety and Traumatic Stress Disorders

Secondary IDs ^††

Study Sponsor ^†

Massachusetts General Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

Mark Pollack, M.D.

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.